Neoepitope-based Personalized DNA Vaccine Approach in Pediatric Patients With Recurrent Central Nervous System Tumors

Conditions

• Pediatric Recurrent Central Nervous System Tumors

Eligibility Criteria

Sex

ALL

Age

N/A - 25 Years

Healthy Volunteers

Not accepted

Interventions

• Personalized neoantigen DNA vaccine — BIOLOGICAL
  At each vaccination time point, patients will receive one injection of the neoantigen DNA vaccine, one injection into the vastus lateralis.
• Papivax Biotech TDS-IM v2.0 — DEVICE
  All study injections will be given intramuscularly using an integrated electroporation device (TDS-IM v2.0 device - Papivax Biotech).
• Peripheral blood draw — PROCEDURE
  -After trial enrollment and up to 7 days after the first vaccine dose (baseline); no more than 2 weeks after the 3rd vaccine dose; no more than 2 weeks after the 6th vaccine dose; two weeks after the last dose; time of progression or discontinuation (optional)

Study Details

The purpose of this research study is to learn about the safety and feasibility of giving a personalized DNA vaccine to people with central nervous system tumors that have returned or have been resistant to treatment.

Key Dates

Start date

Oct 2, 2024

Status verified

May 2026

Primary completion

Mar 31, 2029

Completion

Feb 28, 2031

Study Design

Enrollment

7 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Personalized neoantigen DNA vaccine
  Patients will receive the vaccine monthly (+/- 3 days) for 6 doses as a priming phase followed by booster injections quarterly Q3mo thereafter. If sufficient quantities of vaccine are available, vaccination may continue until development of intolerance or disease progression in the case of fatal high grade neoplasms or for up to one year. Additionally, patients with non-fatal tumors who complete one year of vaccinations and have stable disease at the completion of treatment will be given the option of resuming vaccinations if they develop subsequent progression.

Primary Outcome Measure

Safety and tolerability of adjuvant personalized neoantigen DNA vaccine as measured by the number of grade 3 and 4 adverse events [ Time Frame: Through 30 days after completion of treatment (estimated to be 13 months) ]

Central Contacts

• Michael A Huang, M.D.
  314-454-4146
  [email protected]

Locations (1)

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